OBR Daily Commentary

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FDA Alerts More Doctors Of Rare Cancer With Breast Implants

(Fox News/Associated Press) Feb 7, 2019 - U.S. health officials say doctors should be on the lookout for a rare cancer linked to breast implants after receiving more reports of the disease.

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William McGivney, PhD (Posted: February 11, 2019)

quotesBreast Implants; Déjà Vu All Over Again Last week’s FDA warning regarding the association of breast implants with the occurrence (infrequent) of anaplastic large cell lymphoma (BIA-ALCL) focuses attention yet again on the implications of implanting a foreign object within the human body and the potential for immune system reaction to that object. This latest FDA warning reminds one of the issues raised during the early- to mid-1990s regarding an association of breast implants with the occurrence of autoimmune disease. The latest FDA warning raises a compelling issue for payers: “will payers cover the explanting of breast implants based upon a beneficiary’s concern about possible occurrence of ALCL?”. For payers, the issue revolves around conservative coverage policy regarding preventative services. Generally, private payers reimburse only for preventative services (e.g., mammography, colonoscopy) that are recommended in recognized national guidelines. If a payer views the explantation of breast implants as a preventative service it will likely deny the surgical intervention to remove the breast implant. If there is an actual medical condition (e.g., inflammation due to saline or silicone leakage), a payer may then view the surgical intervention as treatment and provide coverage. The other issue that arises above straight liability issues is: should manufacturers of breast implants be required to pay for the explantation of their breast implants. Twenty-five years ago, when the autoimmune issue arose, there were extensive business/financial conflicts within the major payers (e.g., Aetna, CIGNA) between the interests of the property casualty business within such companies and the health insurance side of the major insurance company. The property casualty components insured many of the breast implant manufacturers and thus were loath to the idea that their health insurer component might force manufacturers to pay. In essence, it would have been property and casualty side paying on behalf of the insured, the manufacturer. It is likely that this FDA warning will not receive the prolonged, highly visible attention given the breast implant-autoimmune disease association but many of the same coverage issues will resurface within the health insurers. quotes

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Prescription Drug Costs Driven By Manufacturer Price Hikes, Not Innovation

(NPR/Shots blog) Jan 7, 2019 - The skyrocketing cost of many prescription drugs in the U.S. can be blamed primarily on price increases, not expensive new therapies or improvements in existing medications as drug companies frequently claim, a new study shows.

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William McGivney, PhD (Posted: January 10, 2019)

quotes ONLY Invested Over $100 Billion in R and D A quote in the summary article provided belies the financial investments and contributions of the biopharma industry to the advancement of science and the resultant delivery of new drugs and biologics to the marketplace and, thus, to patients; (even some agents that are clearly game-changers like immuno-therapeutics). The quote is as follows: “Research and Development is only about 17% of total spending in most large drug companies”. Dare I say that the use of the adverb “ONLY” might evince a “bias” against the biopharma industry no matter how many billions of dollars that biopharma companies invest in biomedical research (basic and mainly clinical). Being generous let’s look at 2017 for the zenith of federal funding to all 27 of the Institutes, Centers, and Offices of the NIH. Budgeted funding was $33.1 billion. Trying to be scientific and methodologically sound, I looked for the spending by biopharma companies in the same year, 2017, on Research and Development. In an online article by John Carroll in Endpoints on April 24, 2017, the author delineates by company budgeted amounts for R and D in 2017. Being a fan of brevity and “get to the point”, I had to go down the list to ONLY company # 4 to best the NIH’s paltry (synonym for ONLY?) $33 billion by $8 billion with a sum for the 4 companies of $41 Billion invested. If one were to go through the list of the top 15, one would tally ONLY $90 billion invested in R and D. I do believe that there are many more biopharma companies out there to tally but I stopped at ONLY 15. To what extent would a reduction in drug prices contribute to a proportional (e.g., percent of 17%) reduction in R and D dollar investments? One can ONLY guesstimate! quotes

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Facing Criticism, CVS May Modify Its New Cost-Effectiveness Program For Covering Some Drugs

(STAT Plus) Sept 18, 2018 - CVS Caremark may revisit a plan that allows its clients to exclude coverage of most new, high-priced drugs after advocacy groups complained the effort would discriminate against very sick or disabled patients.

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William McGivney, PhD (Posted: September 25, 2018)

quotes C-VICER: CVS Embraces ICER We have reached a very sad time when a major corporation (CVS Health) embraces and is willing to integrate the skewed and obtuse work products of the pedantic ICER into treatment coverage decisions about patients diagnosed with cancer. It is always interesting to see companies willing to limit access while wanting at the same time to have a third party to point the finger at. Instead of proceeding, I will quote an important article from OBR Green published on October 19, 2016. After reviewing the ICER analysis on Non-Small Cell Lung Cancer, five eminent lung cancer docs stated: “ICER appears to represent a perspective that is less oriented towards patient benefit than towards motivations that would limit patient access to therapeutic options. ICER’s clinico-economic methods include approaches and metrics that, due to their singular focus on population health, would likely fail patients on an individual clinical needs basis. ICER’s philosophy appears to be similar to that of NICE in the UK, whose limitations placed on drug access have been correlated with lower cancer survival rates in the UK compared to the rest of Western Europe.” “For us as practicing oncologists and lung cancer researchers, this report has raised serious concerns regarding ICER’s ability to interpret clinical evidence and reach conclusions on drug value that are scientific, comprehensive and unbiased.” Enough said! quotes

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Prostate Cancer
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Tomasz M. Beer, MD, FACP

Professor of Medicine, Division of Hematology/Medical O...

Community Oncology
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Dean Gesme, MD

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Debu Tripathy, MD

Professor and Chair, Department of Breast Medical Oncol...

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H. Jack West, MD

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Howard S. Hochster, MD

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Howard Sandler, MD, MS, FASTRO

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Robert A. Figlin, MD., FACP

Professor and Director, Division of Hematology Oncology...

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Ted Okon

Executive Director Community Oncology Alliance...

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Thomas Marsland, MD

Vice President Integrated Community Oncology Network ...

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William Harwin MD

Florida Cancer Specialists President and Managing Part...

Health Policy
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William McGivney, PhD

National Health Policy Expert...

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Winston Wong, PharmD

President, W-Squared Group...